This well established course will explore key phases of pharmacovigilance auditing. It will address the impact of the EU pharmacovigilance legislation on auditing and provide guidance on auditing pharmacovigilance systems at both the global and local organisational level. This course is designed for pharmacovigilance auditors, auditors new to pharmacovigilance and pharmacovigilance professionals to provide them with insight into developing and/or optimising a pharmacovigilance audit programme. In order to gain maximum benefit from the course, an understanding of pharmacovigilance is advantageous.
Tutors will be comprised from the list below:
Director, CM Quality Ltd (Course Principal)
Senior Manager, Allergan Ltd
Otsuka Europe Development and Commercialisation
Global PV QA Consultancy Limited
Johnson & Johnson
"The presentations and workshops were clear and provided useful tools needed for planning, preparation and conducting of PV audits. The examples from real life audits and inspections were great illustrations. The training was also helpful for developing an open mindset with regards to PV auditing."
"Very competent,expert in the PV auditing field. Explained very well and clear."
"Great presenter, gave a good insight of her way of thinking during the audit process, Very knowledgeable."
Please note timings may be subject to alteration
|9.30||Welcome and Introductions and Introduction to the Workshops
The objectives of the workshops are defined and process and outputs described.
|10.00||Pharmacovigilance Audit - Requirements and Expectations
EU PV legislation (relevant Regulations and Directives) and key highlights from Module I, II, IV relating to PV auditing.
||Audit Planning and Scheduling
Understanding and defining the PV Audit universe, applying risk-based audit strategy, using risk assessment and risk criteria, identifying an audit schedule and resourcing audits.
|11.45||Audit Types, Processes and Preparation
Types of PV audits, QA audit process requirements and tools necessary to execute audit programmes.
Detailed information on how to prepare for audits (by audit type), common features in audit preparation and perhaps a table to show differences on preparation by audit types and planning individual audits (eg preparation, audit planning, audit conduct, audit reporting, CAPA management).
|13.30||Auditing Affiliates/Local Operating Companies
Auditing the processes and systems in place at local affiliate offices including post-marketing surveillance, clinical trials, medical information, regulatory, sales/marketing etc.
|14.30||Workshop 1 - Audit Schedule|
|15.30||Workshop 1 - Feedback|
|16.00||Close of day|
|9.00||Case Processing (from all sources)
Auditing the processes and systems designed for processing clinical trial and post marketing cases.
|10.00||Auditing the QPPV and the PSMF
Auditing the roles and responsibilities of the Qualified Person responsible for Pharmacovigilance and the Pharmacovigilance System Master File.
|11.15||Workshop 2 - Planning a System Audit|
|12.00||Workshop 2 - Feedback|
|13.30||Auditing Third Parties
Contracts, safety data exchange agreements, outsourcing and oversight by the Marketing Authorisation Holder.
|14.30||Risk Management Systems Part 1, including:
- Signal management
- Risk management plans and risk minimisation
|16.00||Workshop 3 - Speed Auditing|
|16.45||Close of day|
|9.00||Risk Management Systems Part 2, including:
- PSUR (PBER) and DSUR
- Safety communications (DHPC)
|10.30||Audit Report Writing and CAPA management|
- PV QMS
- Market Research/PSP
- Archiving/Business continuity.
|13.00||Regulatory Inspection and Audit of Quality Assurance
Are your audit programme and quality assurance function inspection ready?
Hints and tips on being the interviewee.
|14.00||Final Wrap Up
An opportunity for open discussion on topics raised during the course or relevant to it.
|15.00||Close of course|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
You will also receive a copy of our booklet - "Pharmacovigilance Auditing"
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.